Whitepapers

See how early supply chain engagement and continuous improvement reduce risk, accelerate tech transfer and time-to-market, and ensure reliable supply for customers and patients—download the white paper to learn more.

Biologics manufacturing is shifting toward integrated ecosystems that align clinical and commercial needs within a unified operational model. Learn how to deliver speed, flexibility, and lifecycle efficiency from early clinical supply to high-volume commercial production.

MaxiPure® Polysorbate 80 is a highly pure excipient designed for high-value injectable applications where control of particles, oxidative stress, and biological compatibility is essential. Fully compliant with Ph. Eur., USP-NF, JP and CP monographs, this non-ionic surfactant is characterized by an oleic acid content above 98%, exceptionally low impurity levels, and outstanding clarity. By combining regulatory excellence with functional performance, MaxiPure® Polysorbate 80 supports the development of stable and safe protein-based therapeutics, and ensures formulation reliability across the drug development lifecycle.

Scaling up a lyophilization process is one of the most technically demanding challenges in biomanufacturing, and even the smallest mistakes can lead to failed batches, delays, and extra costs. This white paper from Jubilant HollisterStier (JHS) shows how choosing the right partner can reduce risk, guarantee quality, and accelerate timelines and features a real-world case study of how JHS lead a successful Phase 3 oncology drug scale-up.

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

The manufacturing landscape is evolving rapidly, marked by ever-increasing competition and consumer demands, unpredictable supply chain disruptions, and the persistent challenge of employee turnover. Optimizing processes and tightening production efficiency has become a top priority for manufacturers across the process industries. Among these processes, efficient mixing stands out as a cornerstone of production, affecting energy consumption, product quality, and operational costs. Yet despite its pivotal role, the benefits of mixing are often underestimated. This article presents five possible strategies that manufacturers can begin to adopt.

This white paper provides actionable insights into FDA expectations, industry best practices, and free tools to mitigate the risk of FDA Observations

This white paper provides actionable insights into FDA expectations, industry best practices, and free tools to mitigate the risk of FDA Observations

Discover the four major hidden cost centers teams tend to overlook when it comes to paper logbooks, along with a real world example showing what happens when a site replaces paper with digital

This white paper offers concise, practical guidance for biopharma teams outsourcing Process Characterization (PC) to strengthen CMC packages and accelerate commercialization.

Microbial cell culture processes are diverse and difficult to harmonize, however, with a new microbial purification platform, downstream processes are streamlined. Applicable for use in E. coli and P. pastoris, this microbial purification platform utilizes a novel scarless protease to reduce purification steps, accelerating the journey from PD to GMP.

Discover how a “Predict-First” approach uses AI-driven in silico models to de-risk mAb development. See real-case results and a manufacturability scoring framework that accelerates decisions and speeds therapies to market.

One of the biggest challenges in pharma production is cohesive, incompatible, or otherwise difficult-to-mix powders. Luckily, mixing technology is advancing and innovative solutions exist to overcome nearly all challenges.

In this paper, Colbert shares information about the recyclability and repulpability of cold foil metallic decoration in packaging. Learn how recent studies validate this sustainability claim.

Laboratory testing validates low migration, low odor, and low VOC in clean, sustainable secondary packaging. Even paperboard with post-consumer recycled content passed the analytical methodology and testing strategy used to ensure sustainability and safety.

Program overview brochure for Ecolab’s Biopharma offering

Commonly observed best practices in facilities where cleaning and disinfection are treated as controlled, optimizable process steps, aligned to contamination control strategies without increasing risk

A Practical Guide to Faster Changeovers, Lower Residue Risk & Stronger Validation Readiness

A practical, decision focused guide to contamination control from design to cleanroom opening